Navigation Links
YM BIOSCIENCES PROVIDES EU REGULATORY UPDATE
Date:12/5/2008

MISSISSAUGA, ON, Dec. 5 /PRNewswire-FirstCall/ - YM BioSciences Inc. (NYSE Alternext US:YMI, TSX:YM, AIM:YMBA), an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today reported that Oncoscience AG, the European licensee of nimotuzumab from YM's subsidiary, CIMYM BioSciences Inc., has withdrawn its application to the European Medicines Agency (EMEA) for marketing authorization of nimotuzumab. Withdrawal of an application does not prejudice the possibility of a company making a new application at a later stage.

The application for the marketing authorization for nimotuzumab was submitted to the EMEA on October 4th, 2007. At the time of the withdrawal it was under review by the Agency's Committee for Medicinal Products for Human Use (CHMP). In its official letter Oncoscience AG states that the withdrawal of the application was made 'because it was not able to adequately address the concerns of the CHMP regarding the quality and efficacy of the medicine within the required time schedule'.

"The questions from EMEA regarding the efficacy of nimotuzumab are based only on data submitted by Oncoscience AG from an unplanned, retrospective, subgroup analysis of a single arm, open label, monotherapy Phase II study of 47 patients with pediatric glioma. This analysis in no manner reflects on the overall efficacy of nimotuzumab, which already has been approved for marketing in twelve countries with efficacy demonstrated in numerous indications," said David Allan, Chairman and CEO of YM BioSciences. "We are very pleased that Oncoscience AG withdrew its application in anticipation of a later resubmission as this application was based on a very small sample that was not prospectively studied. We note that this withdrawal is consistent with actions taken by numerous large and development stage pharmaceutical companies under similar circumstances and we believe it was the correct means for managing the quantity of information that is required in these submissions."

YM's subsidiary CIMYM BioSciences Inc. is the licensee for the highly differentiated EGFR-targeting drug, nimotuzumab, for most of the major market territories including Japan, Europe and North America. Nimotuzumab is already approved for sale in a number of countries and the data continues to demonstrate the prospect for this molecule to be best-in-class in an established area of cancer therapy. It is currently undergoing a YM sponsored confirmatory trial in pediatric glioma in Canada and the US while being advanced in several Phase II and III trials by YM's licensees and other companies advancing the drug internationally.

CIMYM continues with its application to the London Court of International Arbitration for resolution of matters related to the license with Oncoscience AG.

About YM BioSciences

YM BioSciences Inc. is a company that identifies, develops and commercializes differentiated products principally in the area of oncology for patients worldwide. The Company is developing nimotuzumab, a humanized monoclonal antibody, and AeroLEF(R), a proprietary, inhaled-delivery composition of free and liposome-encapsulated fentanyl. Nimotuzumab is in development targeting multiple tumour types in combination with radiation, chemoradiation and chemotherapy. The drug, which is approved for marketing in a number of countries, is significantly differentiated from all other currently marketed EGFR-targeting agents because of a remarkably benign side-effect profile. In more than 3,000 patients treated worldwide, to date, no Grade III/IV rash or radiation dermatitis has been reported and reports of any of the other side-effects that are typical of EGFR-targeting molecules have been rare. AeroLEF(R) is in development for the treatment of moderate to severe pain, including cancer pain. The product completed a randomized trial in 2007 and is being prepared for late-stage development internationally.

This press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that nimotuzumab will continue to demonstrate a competitive safety profile in ongoing and future clinical trials; that AeroLEF(R) will continue to generate positive efficacy and safety data in future clinical trials; and that YM and its various partners will complete their respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


'/>"/>
SOURCE YM BioSciences Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. CeloNova BioSciences Commercializes CATANIA(TM) Coronary Stent With NanoThin Polyzene(R)-F in Europe and Middle East
2. DuPont Applied BioSciences Selects MBI to Collaborate on Process Development and Scale-Up for New Bio-based Product
3. Ellen McDonald Joins Regado Biosciences as Senior Vice President of Business Operations and Chief Business Officer
4. Frost & Sullivan Recognizes Martek Biosciences for Unique and Customer-Focused Strategies With Customer Value Enhancement Award
5. Regado Biosciences to Present at the Piper Jaffray Health Care Conference on Tuesday, December 2, 2008
6. Sangamo BioSciences to Webcast Annual Investor and Analyst Briefing and Presentation at Piper Jaffray Health Care Conference
7. Cyntellect Appoints Former BD Biosciences Executive Andre Lubarsky as Director of Sales - North America
8. Neurocrine Biosciences to Present at the 20th Annual Piper Jaffray Health Care Conference
9. Sangamo BioSciences Appoints Paul Cleveland to Its Board of Directors and Chair of Audit Committee
10. BBM Announces Offer to Acquire YM BioSciences Inc.
11. Sangamo BioSciences Announces Results From Diabetic Neuropathy Clinical Trial SB-509-601
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/23/2016)... , May 23, 2016 - Leading CRO,s ... - Frontage Implement a Single Platform to Manage End-to-end ... Traceability Within the Bioanalytical lab Frontage Laboratories, a full-service ... States and China , has selected ... facilities. In addition to serving as the global electronic lab notebook ...
(Date:5/20/2016)... ... ... Kablooe Design, a leading provider of product design and development services to medical ... “We have worked hard to build long-term relationships,” says President and CEO, Tom KraMer. ... serving their product design and development needs through the years.” , Kablooe has earned ...
(Date:5/19/2016)... There is no saying when ... relentless pressures in pricing and lack in consumer confidence. ... though - numerous opportunities are up for grabs but ... presents four names in this sector: Portola Pharmaceuticals Inc. ... VTAE ), Anthera Pharmaceuticals Inc. (NASDAQ: ...
(Date:5/18/2016)... ... May 18, 2016 , ... Shimadzu ... at The University of Toledo. This two-day camp will take place annually starting ... the field of pharmaceutical sciences in preparation for a university academic program. ...
Breaking Biology Technology:
(Date:4/19/2016)... -- The new GEZE SecuLogic access control ... system solution for all door components. It can be ... interface with integration authorization management system, and thus fulfills ... dimensions of the access control and the optimum integration ... considerable freedom of design with regard to the doors. ...
(Date:4/15/2016)... 15, 2016 Research and ... Biometrics Market 2016-2020,"  report to their offering.  , ... , ,The global gait biometrics market is expected ... the period 2016-2020. Gait analysis generates ... be used to compute factors that are not ...
(Date:4/13/2016)... CHICAGO , April 13, 2016  IMPOWER physicians ... are setting a new clinical standard in telehealth ... By leveraging the higi platform, IMPOWER patients can ... weight, pulse and body mass index, and, when they ... quick and convenient visit to a local retail location ...
Breaking Biology News(10 mins):